Standard of procedures special authorization …

1 1 UPDATED March 3rd, 2014 Standard of procedures special authorization Drugs 1) General Section For all of the following drugs: Claims should be coordinate with the Provincial government program when available. The administration site should be validate for injectable drugs. For Quebec residents, authorization RAMQ criteria predominate on the criteria of this table. drug DISEASE APPROVAL GUIDELINES FIRST CLAIM RENEWAL ABSTRAL (FENTANYL CITRATE) Sublingal Tablet DIN : 02364174 (100 g) DIN : 02364182 (200 g) DIN : 02364190 (300 g) DIN: 02364204 (400 g) DIN: 02364212 (600 g) DIN: 02364220 (800 g) Cancer pain Management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their persistent baseline cancer pain 18 years of age or older 3 months 6 months ACTEMRA (TOCILIZUMAB) Intravenous Solution DIN 02350092 (80 MG / 4 ML) DIN 02350106 (200 MG / 10 ML) DIN 02350114 (400 MG / 20 ML) Rheumatoid Arthritis (RA) Systemic Juvenile Idiopathic Arthritis (JIA) A confirmed diagnosis of moderate to severe rheumatoid arthritis with persistent active disease (8 or more affected joints) And Patients who does not respond to methotrexate adequately at a dose equal to or greater than 15mg per week and to another disease modifying antirheumatic drugs for a period of 3 months or more And One of the following.

2 HAQ > 1 Erosion confirmed by X Ray Increase of SRV or CRP Positive rheumatoid factor 2 years of age or older 5 or more affected joints and failure or contraindications to methotrexate and to another disease modifiying antirheumatic drugs for a period of 3 months or more Or 1 or more affected joints and at least one systemic manifestation (fever, rash, adenomegaly, hepatomegaly, splenomegaly, serous effusion) 5 months 5 months 1 year Improvement of 20 % for affected joints And Improvement of 20 % for SRV or CRP or HAQ or return to work 1 year Improvement of 20 % for affected joints And Improvement of systemic manifestations if appropriate And Improvement of 20 % for SRV or CRP or improvement of CHAQ or return to school 2 drug DISEASE APPROVAL GUIDELINES FIRST CLAIM RENEWAL ADCIRCA (TADALAFIL) Oral Tablet DIN 02338327 (20 MG) Pulmonary Arterial Hypertension (PAH) Treatment of primary pulmonary arterial hypertension (PAH) or PAH associated with connective tissue disease, congenital heart disease or anorexigen use: No response to conventional therapy WHO functional - Class II or III Indefinite N/A AFINITOR (EVEROLIMUS) Oral Tablet DIN 02369257 (2.)

3 5 MG) DIN 02339501 (5 MG) DIN 02339528 (10 MG) Metastatic Renal Cell Carcinoma (RCC) of clear cell morphology Neuroendocrine tumours of pancreatic origin (PNET) Subependymal giant cell astrocytoma (SEGA) Postmenopausal women with advanced breast cancer Second-line treatment in metastatic RCC of clear cell morphology, after failure to VEGF-receptor thyrosine kinase inhibitor (sunitinib or sorafenib): ECOG 2 Treatment of well- or moderately differentiated neuroendocrine tumours of pancreatic origin (PNET): Unresectable, locally advanced or metastatic disease that has progressed within the last 12 months ECOG 2 Treatment of SEGA associated with tuberous sclerosis complex (TSC) that has demonstrated serial growth: 3 years of age or older Not candidate for surgical resection and for whom immediate surgical intervention is not required ECOG 2 Treatment of postmenopausal women with advanced breast cancer: Hormone receptor-positive HER2-negative Associated with aromasin After failure with letrozole or anastrozole 4 months 4 months 4 months 4 months 4 months Absence of progression 6 months Absence of progression 4 months Absence of progression 6 months Absence of progression ALERTEC (MODAFINIL) Oral Tablet DIN 02239665 (100 MG) MODAFINIL (MODAFINIL) Oral Tablet DIN 02285398 Symptomatic excessive sleepiness Symptomatic treatment of excessive sleepiness.

4 Hypersomnia with narcolepsy Hypersomnia associated to sleep apnea despite the use of a CPAP Indefinite N/A APTIVUS (TIPRANAVIR) Oral Capsule DIN 02273322 (250 MG) HIV infection Coordinate with HIV/AIDS Provincial Government Program In combination with other antiretroviral agents in treatment-experienced HIV 1 infected adult patients with evidence of HIV-1 replication and HIV-1 strains resistant to multiple protease inhibitors 6 months 1 year 3 drug DISEASE APPROVAL GUIDELINES FIRST CLAIM RENEWAL ARANESP (DARBEPOETINE ALFA) Intravenous, Subcutaneous Solution DIN 02246354 (10 MCG / 0. 4 ML) DIN 02246355 (20 MCG / 0. 5 ML) DIN 02246357 (30 MCG / 0. 3 ML) DIN 02246358 (60 MCG / 0. 3 ML) DIN 02246360 (150 MCG / 0. 3 ML) Anemia If available, coordinate with the Provincial Government Program Treatment of anemia associated with chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis Or Treatment of Anemia due to Chemotherapy in Patients with Non-Myeloid Malignancies Or AIDS related anemia Indefinite N/A AUBAGIO (TERIFLUNOMIDE) Oral Tablet DIN 02416328 (14 MG) Relapsing-Remitting Multiple Sclerosis (RRMS) Treatment of relapsing-remitting multiple Sclerosis (RRMS): 18 years of age or older Prescribed by a neurologist Monotherapy EDSS Number of disabling clinical relapses in the last 12 months MRI 6 months 1 year AVONEX (INTERFERON BETA-1A) Prefilled Serynge or Autoinjector DIN 02269201 (30 MCG / 0.)

5 5 ML) Relapsing-Remitting Multiple Sclerosis (RRMS) Chronic Progressive Multiple Sclerosis (CPMS) Single demyelinating event with two clinically silent lesions typical of MS (MRI+ ) If available, coordinate with the Provincial Government Program 4 years if EDSS < 4 2 years if EDSS 4 If isolated clinical syndrome (ICS): 1 year 4 years if EDSS < 4 2 years if EDSS 4 ICS : 1 year BANZEL (RUFINAMIDE) Oral Tablet DIN 02369613 (100 MG) DIN 02369621 (200 MG) DIN 02369648 (400 MG) Lennox-Gastaut Syndrome (LGS) Adjunctive treatment of seizures associated with Lennox-Gastaut syndrome: 4 years of age or older Inadequate response or failure to one or more other antiepileptic drugs 6 months 1 year BARACLUDE (ENTECAVIR) Oral Tablet DIN 02282224 (0. 5 MG) Hepatitis B virus infection If available, coordinate with the Provincial Government Program Treatment of chronic hepatitis B virus infection with 0. 5 mg daily No resistance to lamivudine and according viral load Treatment of chronic hepatitis B virus infection with 1 mg daily: Resistance to lamivudine and according viral load Failure of treatment with adefovir or being intolerant to adefovir Indefinite N/A 4 drug DISEASE APPROVAL GUIDELINES FIRST CLAIM RENEWAL BENLYSTA (BELIMUMAB) Intravenous Solution DIN 02370050 (120 MG / 5 ML) DIN 02370069 (400 MG / 20 ML) Systemic Lupus Erythematosus (SLE) Validate the administration site: if in an hospital setting, must be free of charge In addition to Standard therapy in patients with moderate to severe SLE: 18 years of age or older Prescribed by a rheumatologist Autoantibody + (within last 3 months): ANA or dsDNA+ AND SELENA-SLEDAI score 6 and who have not responded (intolerant or contraindicated) to corticosteroid and hydroxychloroquine 6 months 6 months.

6 According to the treatment response Achieving and maintaining an improvement for SELENA-SLEDAI score (score 4 vs initial request) BETASERON (INTERFERON BETA-1B) Subcutaneous Solution DIN 02169649 (0. 3 MG) Relapsing-Remitting Multiple Sclerosis (RRMS) Chronic Progressive Multiple Sclerosis (CPMS) Single demyelinating event with two clinically silent lesions typical of MS (MRI+ ) If available, coordinate with the Provincial Government Program 4 years if EDSS < 4 2 years if EDSS 4 If isolated clinical syndrome (ICS): 1 year 4 years if EDSS < 4 2 years if EDSS 4 ICS : 1 year 5 drug DISEASE APPROVAL GUIDELINES FIRST CLAIM RENEWAL BOTOX (BOTULINUM TOXIN) Intramuscular Solution DIN 01981501 (100 IU) Blepharospasm / Strabismus Cervical dystonia Hyperhidrosis of the Axillae Focal spasticity Chronic migraine Neurogenic detrusor overactivity associated with a neurological condition Validate the administration site: if in an hospital setting, must be free of charge 12 years of age or older Spasmodic torticollis treatment in adult patients Excessive sweating (second-line treatment).

7 Maximum of 200 Units per treatment In the management of focal spasticity, including the treatment of upper limb spasticity associated with stroke in adults For the prophylaxis of headaches in adults with chronic migraine: Headaches lasting 4 hours a day or longer 15 days / month x 3 months Previous medication Maximum of 200 Units per treatment Treatment of urinary incontinence due to neurogenic detrusor overactivity resulting from neurogenic bladder associated with multiple sclerosis or subcervical spinal cord injury: Adults Inadequate response or intolerant to anticholinergic agents 1 year 1 year 1 year 1 year 1 year 1 year Indefinite Indefinite Indefinite Indefinite 1 year 1 year CAPRELSA (VAND TANIB) Oral Tablet DIN 02378582 (100 MG) DIN 02378590 (300 MG) Medullary thyroid cancer Treatment of symptomatic or progressive medullary thyroid cancer in adult patients with unresectable locally advanced or metastatic disease: Adult ECOG 3 3 months 6 months CIALIS (TADALAFIL) Oral Tablet DIN 02296888 (2.)

8 5 MG) DIN 02296896 (5 MG) Benign Prostatic Hyperplasia (BPH) Continuous therapy (2. 5 or 5 mg once a day) Failure to Standard treatment 3 months 6 months CIALIS (TADALAFIL) Oral Tablet DIN 02296888 ( MG) DIN 02296896 (5 MG) DIN 02248088 (10 MG) DIN 02248089 (20 MG) Erectile Dysfunction (ED) NOTE: If no ED clause: not eligible. Treatment of erectile dysfunction (ED) in men (18 years of age or older): Organic erectile dysfunction (e. g., diabetes related, vascular related) Erectile dysfunction with neurological cause (e. g., spinal cord injury (SCI), nerve damage as a result of a prostatectomy or TURP) drug -induced erectile dysfunction where it would be inappropriate to alter the dosage or to discontinue the use of the drug in question Mixed psychogenic/organic erectile dysfunction 1 year Or Indefinite, if annual ceiling 1 year 6 drug DISEASE APPROVAL GUIDELINES FIRST CLAIM RENEWAL CIMZIA (CERTOLIZUMAB PEGOL) Subcutaneous Solution DIN 02331675 (200 MG / ML) Rheumatoid Arthritis (RA) A confirmed diagnosis of moderate to severe rheumatoid arthritis with persistent active disease (8 or more affected joints) And Patients who does not respond to methotrexate adequately at a dose equal to or greater than 15mg per week and to another disease modifying antirheumatic drugs for a period of 3 months or more And One of the following.

9 HAQ > 1 Erosion confirmed by X Ray Increase of SRV or CRP Positive rheumatoid factor 1 year 1 year Improvement of 20 % for affected joints And Improvement of 20 % for SRV or CRP or HAQ or return to work COMPLERA (EMTRICITABINE / TENOFOVIR DISOPROXIL FUMARATE / RILPIVIRINE) Oral Tablet DIN 02374129 (200 MG / 300 MG / 25 MG) HIV infection Coordinate with HIV/AIDS Provincial Government Program In monotherapy for the treatment of HIV-1 infection: Antiretroviral treatment-naive adults HIV-1 RNA 100 000 copies/mL 6 months 1 year COPAXONE (GLATIRAMER ACETATE) Subcutaneous Solution DIN 02245619 (20 MG / ML) Relapsing-Remitting Multiple Sclerosis (RRMS) Chronic Progressive Multiple Sclerosis (CPMS) Single demyelinating event with two clinically silent lesions typical of MS (MRI+ ) If available, coordinate with the Provincial Government Program 4 years if EDSS < 4 2 years if EDSS 4 If isolated clinical syndrome (ICS): 1 year 4 years if EDSS < 4 2 years if EDSS 4 ICS : 1 year DIACOMIT (STIRIPENTOL) Oral Capsule, Powder for Suspension DIN 02398958 (250 MG) DIN 02398966 (500 MG) DIN 02398974 (250 MG / PCK) DIN 02398982 (500 MG / PCK) Refractory myoclonic epilepsy Treatment of refractory generalized tonic-clonic seizures in patients with severe myoclonic epilepsy in infancy.

10 3 years of age or older In conjunction with clobazam and valproate After failure with clobazam and valproate alone 6 months 1 year 7 drug DISEASE APPROVAL GUIDELINES FIRST CLAIM RENEWAL ENBREL (ETANERCEPT) Subcutaneous Solution DIN 02274728 (50 MG / ML) DIN 02242903 (25 MG) Rheumatoid Arthritis (RA) Juvenile Idiopathic Arthritis (JIA) Psoriatic Arthritis (PA) Ankylosing Spondylitis (AS) Chronic moderate to severe plaque psoriasis A confirmed diagnosis of moderate to severe rheumatoid arthritis with persistent active disease (8 or more affected joints) And Patients who does not respond to methotrexate adequately at a dose equal to or greater than 15mg per week and to another disease modifying antirheumatic drugs for a period of 3 months or more And One of the following: HAQ > 1 Erosion confirmed by X Ray Increase of SRV or CRP Positive rheumatoid factor 4 years of age or older 5 or more affected joints and failure or contraindications to methotrexate and to another disease modifiying antirheumatic drugs for a period of 3 months or more 0.